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| Sponsored by: |
Pfizer |
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00625833 |
Purpose
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
| Condition | Intervention | Phase |
|
Diabetic Neuropathies |
Drug: [S,S]-Reboxetine Drug: Placebo |
Phase II |
| MedlinePlus related topics: | Diabetic Nerve Problems Peripheral Nerve Disorders |
| Drug Information available for: | Reboxetine Reboxetine mesylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy. |
| Estimated Enrollment: | 330 |
| Study Start Date: | December 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Placebo: Placebo Comparator |
Drug: Placebo
Oral tablet once a day dosing for 10 weeks.
|
| 2: Experimental |
Drug: [S,S]-Reboxetine
Oral tablet once a day dosing for 10 weeks.
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 57 Study Locations |
| Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
To obtain contact information for a study center near you, click here. 
  |
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6061037 |
| First Received: | February 14, 2008 |
| Last Updated: | November 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00625833 |
| Health Authority: | United States: Food and Drug Administration |
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